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Tenofovir/Levonorgestrel Intravaginal Ring and Tenofovir Intravaginal Ring

NCT03762382 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-01-14

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety, pharmacokinetics and pharmacodynamics of, and the tolerability and acceptance of an intravaginal ring (IVR) delivering both tenofovir and levonorgestrel (TFV/LNG) and an IVR delivering TFV only, compared to a placebo IVR, in women in Western Kenya.

Conditions

  • HIV
  • Contraception
  • Prevention
  • Anti-Retroviral Agent

Interventions

DRUG

TFV/LNG IVR

TFV/LNG IVR is an intravaginal ring that releases approximately 8-10 mg/day of TFV and approximately 20ug/day of LNG to be used for 90 continuous days.

DRUG

TFV IVR

TFV IVR is an intravaginal ring that releases approximately 8-10mg/day of TFV to be used for 90 continuous days.

DRUG

Placebo IVR

Placebo IVR is an intravaginal ring containing no active experimental ingredients to be used for 90 continuous days.

Sponsors & Collaborators

Principal Investigators

  • Nelly R. Mugo, MBChB · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
34 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-12
Primary Completion
2019-08-20
Completion
2020-04-30
FDA Drug
Yes

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03762382 on ClinicalTrials.gov